Apellis Comes Closer To Taking On Alexion In PNH

Besting Alexion’s Soliris in a head-to-head Phase III trial portends a place in the market for Apellis’ competitor in paroxysmal nocturnal hemoglobinuria. But challenges dog both companies.  

3-D Rendering Red Blood Cells
Pegcetacoplan beat Soliris in head-to-head study

Cautious optimism greeted the Apellis Pharmaceuticals Inc. announcement of positive Phase III results for its paroxysmal nocturnal hemoglobinuria (PNH) drug pegcetacoplan, including beating Alexion Pharmaceuticals Inc.’s standard of care Soliris (eculizumab), though analysts raised concerns about the product’s safety profile and want to see more detailed results to better understand the significance of the findings.

Apellis’ pegcetacoplan (APL-2) is a pegylated derivative of the cyclic tridecapeptide compstatin and inhibits complement component (C3) activation. It could...

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

More from R&D

  • ProGen’s Dual Agonist Obesity Contender Gains Momentum With Rani Partnership

     
    • By 

    The CEO of South Korean biotech shares how his company was able to reach a partnership with Rani so quickly and why it is confident in its GLP-1/GLP-2 dual agonist for obesity and diabetes, despite recent disappointing clinical results for its sole rival.

  • Sciwind Eyes Differentiation For Ecnoglutide In Highly Competitive Arena

     
    • By 

    Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.

  • Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

     
    • By 

    Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

  • Sponsored By:

    Nancy Tests SPARC-931-part

    The article discusses the impact of upcoming patent expirations in oncology biologics on biosimilar developers, highlighting the opportunities in Antibody-Drug Conjugates (ADCs) and Bispecific Antibodies (BsAbs). It explores the challenges posed by the structural complexities of these biologics, necessitating new bioanalytical tools and manufacturing processes. The evolving regulatory landscape, with contributions from EMA, FDA, and WHO, offers flexible pathways but also presents challenges. The article underscores the potential for biosimilars to generate significant cost savings and enhance patient access to cancer treatments over the next decade.

More from Scrip